Medical electrical equipment and systems

Manufacturers who wish to place medical electrical equipment onto the European or Great Britain market must obtain CE or UKCA Certification and apply the CE/UKCA mark on their device to demonstrate compliance with the appropriate legislation.

Whilst compliance with the state of art standards is not mandatory for CE/UKCA marking medical electrical equipment, this is the preferred method to demonstrate compliance with the applicable General Safety and Performance Requirements (GSPRs) of the Medical Devices Regulation (MDR) (EU) 2017/745 or with the Essential Requirements (ER) of UK Regulation. As few standards are currently harmonized to the regulations, for manufacturers of medical electrical equipment to be assessed against the Regulation, understanding and meeting the requirements of EN 60601 is crucial. EN 60601 represents a state-of-the-art standard and can therefore be applied to show conformity with the applicable MDR and UK Regulation requirements

EN 60601-1 applies to all medical electrical equipment and medical electrical systems. Medical electrical equipment is defined in the standard as equipment which:

• Has an applied part – that of the medical electrical equipment which, in normal use, necessarily comes into physical contact with the patient for the medical electrical equipment or system to perform its function.

OR

• Transfers energy to or from the patient.

The medical electrical equipment should be provided with only one connection to a particular power supply. The intended use, as described by the manufacturer, should be aimed at the diagnosis, treatment, or monitoring of a patient, or to alleviate or compensate for disability, disease, or injury.